1. Field of the Invention
This invention relates to a vial access adapter connected to a vial which contains a medical fluid therein and is closed by an elastomeric stopper. In particular, it relates to a vial access adapter for use with a vial which is enshrouded or contained in a protective cover which shields medical personnel from radiation. The vial access adapter allows withdrawal of a maximal amount of medical fluid (particularly a radioactive medical fluid) without inverting the vial.
2. Reported Developments
Vials made of glass or polymeric materials, the walls of which are non-collapsible, require an air inlet when medical fluid is withdrawn therefrom to prevent the formation of vacuum therein. Typically, vials containing a medical fluid are closed by rubber stoppers which are pierced by a dual spike having a medical fluid passage and an air inlet passage therein. The air inlet passage contains a filter to prevent entry of particulate matter or bacteria into the vials during a medicament withdrawal process.
An improvement in the present invention over the prior art is the spatial configuration of the medical fluid access spike which, on positioning of the vial access over a vial having a rubber stopper, allows essentially complete withdrawal of the medical fluid contained in the vial.
The present invention comprises at least three embodiments. In a first embodiment the medical fluid access spike penetrates the rubber stopper and just clears the bottom surface of the rubber stopper. The vial, to which the vial access adapter is attached, is turned upside during the withdrawal process. In a second embodiment the medical fluid access spike penetrates the rubber stopper and extends to the bottom of the vial. The vial in this embodiment is held in an upright position during the withdrawal process. Both embodiments allow essentially complete withdrawal of the medical fluid contained in the vial.
A third embodiment of the present invention concerns handling large and/or heavy liquid drug containers and specifically containers for radioactive fluids (e.g. nuclear drugs such as diagnostic or therapeutic radiopharmaceuticals or other radioactive fluids).
Based on the safety guidelines issued by the Food and Drug Administration, including the 1991 Bloodborne Pathogens Standard (29 CFR 1910.1030) and the most recent revision to that standard (H.R. 5178), medical device manufacturers are instructed to strengthen safety requirements relating to the use of safety-engineered sharp devices. Typically, medicaments contained in vials are accessed using a steel needle or with a point-of-use needle less adapter.
When vials contain radioactive fluids such as radiopharmaceuticals it is required that shielding is in place in front of the technician or other operator who removes products from the vial for administration to patients. In addition, it is also required that the radioactive fluid itself is placed in a protective container, often referred to as PIG, that is generally constructed of lead, a lead-containing alloy. This latter requirement is difficult to meet considering, for example, that a lead PIG for a 30 ml vial could weigh up to seven pounds. Inverting the vial and inserting the steel needle to remove some or all of its contents is extremely difficult due to the weight of the PIG. Since the vial is held upside-down in the PIG cover, a means to hold the vial in the PIG is necessary so that it does not fall out by the affect of gravity. Attempts were made to hold the vial in the PIG by friction fit. However, this made the removal of the vial from the PIG unsafe and difficult due to the force required to remove the vial from the PIG. When a vial is nearly empty, the radio pharmacist or other operator has to manipulate the steel needle, whether the vial is right-side-up or upside-down, to ensure that as much of the nuclear drug as possible is removed from the vial to minimize waste.
The present invention addresses this requirement by providing a vial having a flat, concave, V-shaped bottom and a needle less access means which allow close to complete removal of the nuclear medicine contained in the vial standing right-side-up on a table top or a similar flat horizontal surface.